title: Tolerability of oral ziprasidone in children and adolescents with bipolar mania, schizophrenia, or schizoaffective disorder.
abstract: OBJECTIVE
  This study characterizes the tolerability of ziprasidone in children and adolescents with bipolar mania, schizophrenia, or schizoaffective disorder.
  
  
  METHODS
  Sixty-three subjects (aged 10-17 years) entered an open-label study consisting of a 3-week fixed-dose period (Period 1) and a subsequent 24-week flexible-dose period (Period 2). In Period 1, subjects received ziprasidone 80 or 160 mg/d in two divided doses, titrated over 10 days. In Period 2, subjects received flexible doses (20-160 mg/d). Tolerability was evaluated using movement rating scales, laboratory tests, and electrocardiograms. Clinical response was assessed using the Young Mania Rating Scale, the Brief Psychiatric Rating Scale-Anchored Version, and the Clinical Global Impressions-Severity scale.
  
  
  RESULTS
  Adverse events (AEs) occurred mostly during dose titration and in the high-dose (160 mg/d) group. The most common AEs during Period 1 were sedation (32%), somnolence (30%), and nausea (25%) and during Period 2 were sedation (30%), somnolence (30%), and headache (25%). The incidence of movement disorder AEs was 22% and 16% during Periods 1 and 2, respectively. Six percent of study participants discontinued study participation due to AEs during Period 1 and 20% discontinued in Period 2. Thirty-three percent of subjects gained >or=7% of their baseline weight. No Fridericia-corrected QT (QTcF) intervals of >450 ms were observed during Period 1 and only one occurred during Period 2. No QTcF increase >or=60 ms from baseline was observed. Symptom reductions were observed in all patient groups.
  
  
  CONCLUSIONS
  No unexpected tolerability findings were observed in this prospective trial of ziprasidone in children and adolescents with bipolar mania, schizophrenia, or schizoaffective disorder. On the basis of the results, a starting dose of 20 mg/d titrated to between 80 and 160 mg/d over 1-2 weeks appears optimal for most patients.
authors.affiliation: University of Cincinnati College of Medicine, Department of Psychiatry, Cincinnati, Ohio 045267, USA. delbelmp@email.uc.edu
authors.forename: Melissa P
authors.initials: MP
authors.lastname: DelBello
authors.forename: Mark
authors.initials: M
authors.lastname: Versavel
authors.forename: Kathleen
authors.initials: K
authors.lastname: Ice
authors.forename: David
authors.initials: D
authors.lastname: Keller
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Miceli
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D001714:Bipolar Disorder / Q000188:drug therapy*; D002648:Child; D004305:Dose-Response Relationship, Drug; D004562:Electrocardiography; D005260:Female; D006801:Humans; D008297:Male; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D011618:Psychotic Disorders / Q000188:drug therapy; D012559:Schizophrenia / Q000188:drug therapy*; D012720:Severity of Illness Index; D013844:Thiazoles / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D013844:Thiazoles; C092292:ziprasidone